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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ARTIS Q.zen

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  Class 2 Device Recall Siemens ARTIS Q.zen see related information
Date Initiated by Firm October 19, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-0459-2019
Recall Event ID 81514
510(K)Number K123529  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS Q.zen biplane with Material 10848355
- a Angiographic x-ray system

Product Usage:
Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information Serial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support
FDA Determined
Cause 2		 Device Design
Action Siemens issued on 10/19/18 an Urgent Medial Devoce Correction notification to via AX033/18/S advising users of the problem, health risk, steps to be taken. Siemens has initiated screw connection exchange of the ceiling bearing via Update Instruction AXOSS/17 /S.
Quantity in Commerce 15
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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